COVID-19: what will be the ‘new normal’?
A number of changes to society and the economy have emerged during the COVID-19 pandemic, which are likely to impact regulators, HTA agencies and the pharma industry. CIRS recently hosted [...]
CIRS RD Briefing 77 – New drug approvals in six major authorities
This Briefing presents the results from the CIRS annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
Mohd Sani et al 2020 – Evaluation of the Malaysian regulatory process using OpERA methodology
Introduction: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides [...]
Sithole et al 2020 – Evaluating the success of ZaZiBoNa
The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]
CIRS RD Briefing 76 – Mexican therapeutic landscape
An efficient regulatory process can be reflected in measurable positive health impacts; conversely, activities that slow or impede regulatory efficiency and predictability can be detrimental. Recent developments in the [...]
Updated list of CIRS workshops
Unfortunately, given current circumstances, we have had to postpone our June workshop. Please see below for our revised list of workshops. 15-16 September, Bogota, Columbia Effectiveness of the regulatory [...]
CIRS RD Briefing 75 – Emergency Use Pathways (EUPs)
It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these [...]
CIRS selected as Technical Partner for PQM+ programme
We’re delighted to announce that we’ve been selected as a Technical Resource Partner for the Promoting the Quality of Medicines Plus (PQM+) programme, which is funded by the US Agency [...]
Revised list of CIRS workshops
Unfortunately, given current circumstances, we have had to postpone our March workshop. Please see below for our revised list of workshops. 11-12 June, Tyson's Corner, USA Digital health: exploring the [...]
CIRS Awarded a Grant to Help Accelerate Registration of Medicines in Low and Middle Income Countries
We’re delighted that the Bill and Melinda Gates Foundation is continuing to support our work with medicine regulatory agencies in low- and middle-income countries (LMICs) through the OpERA programme. The [...]